Senior Pharmacovigilance Specialist -EAC - Johannesburg
Abbott Laboratories
About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of . A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Roodepoort Offices, Abbott Place in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the world's fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. The role of Pharmacoviligence Specialist ensures that all activities related to pharmacovigilance (PV) for both Abbott EPD investigational and registered medicinal products are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirement. What You'll Do: Acts as a local QPPV on a 24/7/365 basis in EAC Affiliate. Maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance Receipt, recording, and reconciliation of safety information Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans Regulatory submission of safety information Basic PV training of local EPD staff PV record retention and archiving Implementation of out-of-office coverage for receiving and recording safety-relevant information Maintenance of local PV product list Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes. Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization. Provision of local PV Compliance metrics and management of non-compliances Coordination/management of PV audits and inspections at the Affiliate level Ensure vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements. Contribution to benefit-risk assessment of the Abbott EPD products portfolio; Act as the key expert for any PV-relevant topics and ensures proactive communication as appropriate; Leading regional PV projects and contribution to global PV projects. Required Qualifications Pharmacy or related health science degree Preferred Qualifications At a minimum 4 years PV experience in pharmaceutical industry or PH Health authority. . Profound understanding of local PV regulation Ability to give attention to the detail. Computer literacy (Windows, MS Office) Good English language skills Good communication skills with internal and external stakeholders Excellent time management, organizational and planning skills. The ability to work independently and as a part of a team. Independent thinker with the ability to challenge the status quo with outstanding interpersonal skills. Apply Now Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter AbbottNews and AbbottGlobal.
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